Dear Colleagues,

The business model for clinical trial operations has not evolved to keep pace with the promise that new technology offers.  Operations have become more complex, often in response to news of adverse regulatory actions, rather than being guided by evidence about which approaches are most effective.  As a result, randomized clinical trials have grown increasingly complex, costly, and slow to complete.  Without more certainty about the outcomes one might expect with new approaches to clinical trial operations, research sponsors are often reluctant to try them.  Workable solutions are most likely to emerge from collaboration across sectors that seeks to maximize efficiency, while minimizing the risks to all parties involved— clinical trial participants, research sponsors, investigators, and regulators charged with protecting the public health.

To develop such workable solutions, a public-private partnership -- the Clinical Trials Transformation Initiative (CTTI) -- was established in 2008 by the U.S. Food and Drug Administration (FDA) and Duke University.  Today CTTI has broad participation from over 60 member organizations representing the full spectrum of those involved in clinical research.

CTTI’s approach includes conducting projects to better understand the range of current practices, assess alternative approaches, understand barriers to change, and propose recommendations for improvement.  Members contribute ideas for projects, participate in their conduct and analysis, and are committed to disseminating CTTI recommendations and encouraging adoption of system changes that will improve the efficiency of clinical trials.  Funding from member organizations provides support for projects and infrastructure, according to a fee schedule published on the CTTI website.  The Executive Committee oversees the use of these funds.   

If your organization is interested in working with others to identify ways to make clinical trials more efficient and of higher quality, we invite you to participate in this initiative.  Ultimately the remedy for our ailing clinical research system depends on the collective effort of all constituents involved in the clinical trials process; CTTI provides an optimal venue for this collaboration.  I hope you will consider participating in this exciting partnership.  Please view our membership section to learn more about CTTI membership and how to join.

Thank you,

Robert M. Califf, M.D.
Co-Chair, CTTI
Vice Chancellor for Clinical Research, Duke University